A method and the apparatus for anastomosing two hollow viscera that can be performed percutaneously or through the patients mouth. The apparatus includes an anchor assembly including a stationary T-bar anchor secured to the distal end of a suture and a sliding anchor that is attached to the suture proximal to the stationary T-bar anchor. The sliding anchor is held in place on the suture but can be slid along the suture when pressure is applied to it. The anchor assembly is inserted through the abdominal wall, into the stomach, and then through the stomach into the jejunum. The stationary anchor is then released into the jejunum and the sliding anchor is released in the stomach. A pusher is then used to push or slide the sliding anchor distally until the tissue between the stationary and sliding anchors are in close contact. After the anchor has been placed, the suture can be severed at the sliding anchor.
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8. The method for forming an anchor between first and second adjacent hollow viscera, comprising the steps of:
(a) selecting the area where the anchor is to be formed; (b) providing a tract from outside of the body, to the interior of the first hollow viscus and through the adjacent walls of the first and second hollow viscera in the area where the anchor is to formed; (c) providing an anchor assembly comprising a suture having a stationary anchor secured to its distal end and a sliding anchor slidably attached to the suture proximal to the stationary anchor; (d) attaching said sliding anchor to said suture such that it does not move relative to the suture unless a force is applied to the sliding anchor in a direction longitudinally along the suture (e) positioning the anchor assemble, through said tract, to the area where the anchor is to be formed; (f) depositing said stationary anchor in said second hollow viscus; (g) depositing said sliding anchor is said first hollow viscus; (h) placing the anchor by applying a force to said sliding anchor, through said track, to position said sliding anchor against the wall of said first hollow viscus with the adjacent walls of the viscera held flush together between the stationary and sliding anchors.
13. A device for percutaneously placing an anchor between the walls of a first and second adjacent hollow viscera, comprising:
a tract that extends percutaneously from outside of the body, to the interior of the first hollow viscus and through the adjacent walls of the first and second hollow viscera in the area where the anchor is to be placed; an anchor assembly, comprising a suture having a stationary anchor secured to its distal end and a sliding anchor slidably attached to the suture proximal to the stationary anchor; the attachment of said sliding anchor to said suture being such that the sliding anchor will not move relative to the suture unless a force is applied to the sliding anchor in a direction longitudinally along the suture; said stationary and sliding anchors being dimensioned to be received sequentially in said tract such that they can be slid through the tract to the area where the anchor is to be placed with the stationary anchor leading and the sliding anchor following; a force applying mechanism that can extend through said track to the area where the anchor is to be placed at which it can engage the sliding anchor and apply a force thereto to slide the sliding anchor longitudinally along the suture; said sliding anchor being attached to said suture such that it does not move relative to the suture unless a force is applied to the sliding anchor in a direction longitudinally along the suture.
1. A method for forming an anastomosis between first and second adjacent hollow viscera, comprising the steps of:
(a) selecting the area where the anastomosis is to be formed; (b) providing a tract from outside of the body, to the interior of the first hollow viscus and through the adjacent walls of the first and second hollow viscera in the area where the anastomosis is to be formed; (c) providing an anchor assembly comprising a suture having a stationary anchor secured to its distal end and a sliding anchor slidably attached to the suture proximal to the stationary anchor; (d) attaching said sliding anchor to said suture such that it does not move relative to the suture unless a force is applied to the sliding anchor in a direction longitudinally along the suture; (e) positioning the anchor assembly, through said tract, in the area where the anastomosis is to be formed; (f) depositing said stationary anchor in said second hollow viscus; (g) depositing said sliding anchor in said first hollow viscus; (h) placing the anchor by applying a force to said sliding anchor through said track to position said sliding anchor against the wall of said first hollow viscus with the adjacent walls of the viscera held flush together between the stationary and sliding anchors; (i) providing a tract from outside of the body, through which the anastomosis is to be formed, to the area where the anastomosis is to be formed and adjacent to where the walls of the viscera have been anchored together; (j) piercing the adjacent walls of the hollow viscera in the area where the anastomosis is to be formed and adjacent to where the anchor was placed; (k) dilating the aperture formed by piercing the adjacent walls of the hollow viscera to form the anastomosis of the size desired.
2. The method for forming an anastomosis as set forth in
(l) repeating steps (a) through (h) to place multiple anchors in the area where the anastomosis is to be formed.
3. The method for forming an anastomosis as set forth in
providing a length of coil spring and a cylindrical-shaped mandrel that can be received within the coil spring; and passing the suture through adjacent coils of the coil spring such that the suture wraps around a coil and is engaged between the coil that it wraps around and the coils on opposite sides of the coil that it wraps around; providing a mandrel of a size that can be inserted in the length of coil spring; inserting the mandrel in the coil spring such that the mandrel is in engagement with the portion of the suture that is wrapped around the coil spring.
4. The method for forming an anastomosis as set forth in claims 1 or 2 or 3 wherein the method further includes the step of:
(m) severing the portion of the suture that is distal of the placed anchor.
5. The method for forming an anastomosis as set forth in claims 1 or 2 or 3 wherein the method further includes the step of:
(n) placing a stent in the dilated aperture formed in the adjacent walls of the hollow viscera.
6. The method for forming an anastomosis as set forth in claims 1 or 2 or 3 wherein the force applied to said sliding anchor to position said sliding anchor against the wall of said first hollow viscus is in the range of 250-500 grams.
7. The method for forming an anastomosis as set forth in claims 1 or 2 or 3 wherein the following additional steps are performed:
(o) providing stationary and sliding anchors that have elongated shapes; (p) securing said sutures to the elongated stationary anchor at a mid-portion of the elongated stationary anchor; and (q) attaching said suture to the elongated sliding anchor at a mid-portion of the elongated sliding anchor.
9. The method for forming an anchor between first and second adjacent hollow viscera, comprising the steps of as set forth in
providing a length of coil spring and a cylindrical-shaped mandrel that can be received within the coil spring; and passing the suture through adjacent coils of the coil spring such that the suture wraps around a coil and is engaged between the coil that it wraps around and the coils on opposite sides of the coil that it wraps around; providing a mandrel of a size that can be inserted in the length of coil spring; inserting the mandrel in the coil spring such that the mandrel is in engagement with the portion of the suture that is wrapped around the coil spring.
10. The method for forming an anchor as set forth in claims 8 or 9 wherein the method further includes the step of:
(n) severing the portion of the suture that is distal of the placed anchor.
11. The method for forming an anchor as set forth in claims 8 or 9 wherein the force applied to said sliding anchor to position said sliding anchor against the wall of said first hollow viscus is in the range of 250-500 grams.
12. The method for forming an anchor as set forth in claims 8 or 9 wherein the following additional steps are performed:
(o) providing stationary and sliding anchors that have elongated shapes; (p) securing said sutures to the elongated stationary anchor at a mid-portion of the elongated stationary anchor; and (q) attaching said suture to the elongated sliding anchor at a mid-portion of the elongated sliding anchor.
14. A device for percutaneously placing an anchor between the walls of a first and second adjacent hollow viscera, as set forth in
the attachment of said sliding anchor to said suture being such that the sliding anchor will not move relative to the suture unless a force in the range of 250-500 grams applied to the sliding anchor in a direction longitudinally along the suture.
15. A device for percutaneously placing an anchor between the walls of a first and second adjacent hollow viscera, as set forth in claims 13 or 14 further comprising:
said sliding anchor comprising a length of coil spring and a cylindrical-shaped mandrel that can be received within the coil spring; and the attachment of the coil spring to the suture is accomplished by passing the suture through adjacent coils of the coil spring such that the suture wraps around a coil and is engaged between the coil that it wraps around and the coils on opposite sides of the coil that it wraps around, and the mandrel is within the coil spring in engagement with the portion of the suture that is wrapped around the coil spring.
16. A device for percutaneously placing an anchor between the walls of a first and second adjacent hollow viscera, as set forth in claims 13 or 14 and further comprising:
a suture severing mechanism having a sharp distal edge that can be advanced through the catheter to the area where the anchor is to be placed to sever the suture at the sliding anchor after the anchor has been placed.
17. A device for percutaneously placing an anchor between the walls of a first and second adjacent hollow viscera, as set forth in claims 13 or 14 and further comprising:
said stationary and sliding anchors that have elongated shapes; said suture secured to the elongated stationary anchor at a mid-portion of the elongated stationary anchor; and said suture secured to the elongated sliding anchor at a mid-portion of the elongated sliding anchor.
18. A device for percutaneously placing an anchor between the walls of a first and second adjacent hollow viscera, as set forth in
said length of coil spring having an outside diameter of about 0.038 inch and said cylindrical-shaped mandrel having a diameter of about 0.018 inches.
19. A device for percutaneously placing an anchor between the walls of a first and second adjacent hollow viscera, as set forth in
said length of coil spring having an outside diameter of about 0.038 inch and said cylindrical-shaped mandrel having a diameter of about 0.018 inches.
20. A device for percutaneously placing an anchor between the walls of a first and second adjacent hollow viscera, as set forth in
said length of coil spring having an outside diameter of about 0.038 inch and said cylindrical-shaped mandrel having a diameter of about 0.018 inches.
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Because of the invasive nature of traditional surgery there are inherent risk and objectionable side effects associated therewith. For example if a patient is found to have an inflammatory stricture in the small intestine and it is decided to surgically remove the section of the intestine containing the stricture and reconnect the severed ends of the intestine by sutures. Such invasive surgery requires a general anesthesia, is time consuming, expensive and is painful and requires a long healing process. As a result less invasive procedures are being developed as alternatives to traditional surgical procedures.
Draining viscera, such as the stomach or gall bladder, can be performed through a track inserted percutaneous into the viscera, however, there is the danger that gastric juices, bile or infected fluids could spill into the peritoneal cavity. To prevent this, procedures and devices have been developed to pull and anchor the wall of the viscera into contact with the abdominal wall using sutures anchor devices that are inserted into the cavity of the viscera through thin hollow needles. With the viscera thus stabilized with its wall held flush against the abdominal wall, drain tubes can be inserted into the viscera without the danger of spillage into the peritoneal cavity. Examples of viscera anchor of this type are shown in U.S. Pat. Nos. 5,123,914 and 6,110,183. The anchors disclosed in U.S. Pat. Nos. 5,123,914 and 6,110,183 are constructed to prevent damage to the interior of the viscus and can be inserted and removed through small diameter needles.
Another method and device, now in use, that avoid the trauma of traditional surgery, is a method and apparatus for creating abdominal visceral anastomoses. This method and device, is disclosed in U.S. Pat. No. 5,690,656, uses a pair of powerful magnets, each having a raised rim around their perimeter. The patient swallows one magnet, then waits until it has worked its way into the jejunum, then the patient swallows the second magnet which works its way into the stomach. The location of the magnets can be monitored and manipulated such that they become attracted to each through the walls of the stomach and the jejunum. The magnets apply pressure to the tissue that is held between the raised rims. After a few days, the tissue between the magnets becomes necrotic and the two magnets together pass into the jejunum and eventually pass through the bowel. A stent can then be endoscopically placed in the resulting opening, to prevent the opening from closing. The procedure disclosed in U.S. Pat. No. 5,690,656, although less invasive than traditional surgery, extends over a several day period and the precise placement of the magnets is problematic. Thus, a one-step procedure and apparatus for anastomosing two hollow viscera by a percutaneous technique in which the surgeon has greater control over the location of the anastomosis is needed.
The present invention relates to a method and the apparatus for anastomosing two hollow viscera using a technique that is an improvement over the method and apparatus discussed above. This technique can be performed percutaneously but could also be performed through the patients mouth. The suture anchor is modified by adding a T-bar to the suture that can be caused to slide along the suture to a position proximal to the stationary suture anchor that is located at the distal end of the suture. A hollow needle containing this improved anchor assembly devise pierces the patient's abdominal wall, extends into the stomach and then through the stomach into the jejunum. The stationary anchor, carried at the distal end of the suture, is then released into the jejunum and the needle is withdrawn back into the stomach where the sliding anchor is released from the needle. The needle is then withdrawn leaving the suture extending from the anchors out through the needle hole in the abdominal wall. The needle is then replaced, over the suture, by a small dilator/pusher. The pusher is then used to push or slide the sliding anchor distally until the tissue between the stationary and sliding anchors are in close contact. After the anchor has been placed, the suture can be severed at the sliding anchor. Depending upon the size and location of the viscera between which the anastomosis is to be formed, the number of anchors that will be placed may be one or multiple. In the example disclosed herein, several anchors were placed to create an area of tissue contact between the outer surfaces of the viscera. This area of tissue contact is then penetrated by another needle and a wire guide is placed through this newly created aperture, over which a sheath dilator combination is placed. The size of the puncture formed in the area of tissue contact is enlarged and a stent is placed through the puncture. The stent can be a Z-type stent which is a self-expanding stent formed of stainless steel wire that is arranged in a closed zigzag pattern. The Z-stent is compressed into a reduced size shape so that it can be placed in passageway in a patient by means of a sheath. Reference may be made to U.S. Pat. No. 4,580,568 for a completed disclosure of a Z-stent.
This technique for anastomosing two hollow viscera has advantages over the method disclosed in U.S. Pat. No. 5,690,656 since it is much faster, it being completed in one visit as opposed to at least two visits that are days apart. Also, this method allows the surgeon more control over the exact location of the anastomosis.
Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings; however, the present invention is not limited to the embodiments described below.
This invention concerns a technique, using a sliding anchor 30, for anastomosing two hollow viscera. The invention will be illustrated and will be described, with reference to a percutaneous technique for anastomosing the stomach 10 and the jejunum 12 through the body wall. However, the same technique could be performed through the patients mouth by using a gastroscope with appropriately sized equipment. Other applications for this technique are for example cholecystoduodenostomy, cholecystodochotom, choledochogastrostomy, ileocolostomy, portocaval shunt, and percutaneous colostomy.
An embodiment of the sliding anchor 30 will be described with reference to
The force required to start the anchor 30 sliding on the suture 34 should be about 250-300 grams but in some situations should be as high as 500 grams. The desired force can be changed by increasing the diameter of the mandrel 36, for example to 0.022 inches, by using a tighter coil spring 32, a larger gauge suture, or a more tacky suture.
Refer now to
Preliminary to performing the anastomosing technique, a sheath 50 could be inserted percutaneously into the stomach 10 to opacify the proximal jejunum with air and a contrast medium.
Refer now to
Shown in
Once the anchors are locked together, the pusher rod 58 can be removed from the catheter 50 and, as illustrated in
It is also contemplated to construct the anchors from a plastic which will dissolve after several weeks when visceral adhesion has been well established.
The above procedure is repeated one or more times to install additional pairs of anchors around the anastomosis area A. When the visceral walls are securely held together by multiple pair of anchors the area between the multiple anchors can be needled, a guide wire inserted and the tract can be safely dilated and a large stent inserted.
An example of the type of stent that could be used in this situation is illustrated in
Another embodiment of applicant's invention is shown in
The assembly 60 is guided through a catheter (not shown), similar to catheter 50 of the embodiment shown in
Another embodiment of applicant's invention is shown in
The assembly 80 is guided through a catheter (not shown), similar to the catheter of the embodiment disclosed in
The following procedure was performed and results were obtained on three swine.
A 10F sheath was inserted percutaneously in the inflated stomach of the swine to opacify the proximal jejunum with air and to provide a contrast medium.
A second 10F gastrostomy sheath was inserted percutaneously in the stomachs of the swine through which a 5.5F Teflon catheter was inserted which punctured the back wall of the stomach and extended into the jejunum. A single gastric anchor was inserted in the jejunum and a guide wire was advanced into the small bowel.
An anchor assembly, consisting of a stationary anchor secured to the distal end of a suture and a sliding anchor attached to the suture proximal to the stationary anchor, was advanced through the 5.5F Teflon catheter which extended through the back wall of the stomach and into the jejunum at a location to one side of the guide wire. The stationary anchor was pushed out of the catheter with a catheter pusher and deposited into the jejunum. The catheter was then pulled back into the stomach where the sliding anchor was pushed out into the stomach and pushed along the suture to a position snug against the gastric wall. The suture was cut proximally of the sliding anchor. The above procedure was repeated several times to place multiple anchors between the stomach and jejunum walls at locations surrounding the area where the anastomosis was to be formed. These anchors maintained the apposition of the gastric and jejunal walls while the aperture in these walls through which the guide wire extended was dilated and a stent was inserted without intraperitoneal leakage.
At postmortem examination, 6-12 days later, there was excellent visceral adhesion at the anastomosis around the stent.
While the invention has heretofore been described in detail with particular reference to illustrated apparatus, it is to be understood that variations, modifications, and the use of equivalent mechanisms can be effected without departing from the scope of this invention. It is, therefore, intended that such changes and modifications be covered by the following claims.
It is intended that the accompanying drawings and foregoing detailed description is to be considered in all respects as illustrative and not restrictive. The scope of the invention is intended to embrace any equivalents, alternatives, and/or modifications of elements that fall within the spirit and scope of the invention, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
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